KEYNOTE: Steve Anderson, Chief Scientific Officer and Senior Vice President, Covance
Dr. Anderson is a senior vice president at Laboratory Corporation of America (LabCorp), and the chief scientific officer for the Covance Drug Development business of LabCorp. He has been with the LabCorp organization for 26 years and has held a variety of positions including director of operations for ViroMed Laboratories, director of operations for Monogram Biosciences, director of operations for the Center for Molecular Biology and Pathology, director of operations for Integrated Oncology and Genetics, national director of Research and Development, and global head of LabCorp Clinical Trials. Dr Anderson is a member of a variety of professional societies including the American Association for Cancer Research, the American Society of Clinical Oncology and the Association for Molecular Pathology. Dr Anderson’s research interests are in the development and applications for molecular diagnostics, including several examples of companion diagnostics and pharmacogenomics assays. He has authored more than 175 articles and abstracts published in such journals as Genetics, Proceedings of the National Academy of Sciences, Clinical Chemistry, the Journal of Infectious Disease, Human Pathology, American Journal of Obstetrics and Gynecology, Oncogene, the Journal of the National Cancer Institute, Clinical Cancer Research, Breast Cancer Research, BMC Cancer, the Journal of Molecular Diagnostics, Archives of Pathology and Laboratory Investigation and Expert Reviews in Molecular Diagnostics.
KEYNOTE: Jeff Evelhoch, Vice President, Head of Translational Biomarkers, Merck & Co.
Dr. Jeffrey L. Evelhoch is vice president, Early Stage Development and head, Imaging at Merck Research Laboratories (MRL). In this role Jeff, provides leadership and coordination for the use of Preclinical and Clinical Imaging resources for all MRL franchises and functions. He ensures that imaging biomarkers are used optimally in the Target through IIB space and in late stage development to help advance Merck’s compounds through to registration. Dr. Evelhoch joined Merck in 2008, after four years at Amgen as executive director, Medical Sciences and head, Imaging Sciences. He also worked at Pfizer Global Research & Development and Pharmacia Corporation and was on the faculty of Wayne State University School of Medicine for 18 years, where he was a professor of Internal Medicine, Radiology and Cancer Biology. Dr. Evelhoch was named a Fellow of the International Society of Magnetic Resonance in Medicine (ISMRM) in 2003. He is actively involved in the joint efforts of professional organizations, industry groups and federal agencies to further the development and use of quantitative imaging, including The Biomarker Consortium, the Quantitative Imaging Biomarker Alliance and the ISMRM Ad Hoc Committee on Standards for Quantitative Magnetic Resonance. Dr. Evelhoch has a B.S. in chemistry from West Chester University and received his Ph.D. and M.S. in analytical chemistry from the University of California at Riverside. He was also a postdoctoral fellow at Washington University in St. Louis. Throughout his career, he has actively published and served on National Institutes of Health review committees; he is currently a member of the National Cancer Institute’s Experimental Therapeutics (NExT) Special Emphasis Panel.
Esther Abels, VP Regulatory Affairs, Clinical Affairs and Strategic Business Development, PathAI
Esther Abelsis is VP of Regulatory & Clinical Affairs and Strategic Business Development at PathAI. She graduated in Biomedical Health Science, toxicology. Experienced in clinical validation studies used for regulatory purposes in USA, Europe and Asia. Has a background in bridging R&D, Proof of Concept and socio economics studies. Was Clinical Research Scientist and Global Clinical Trial Manager for pivotal regulatory studies in both pharma and biotech. Worked and lived in NL as well as USA prior to relocating to Boston USA to join PathAI in 2018. She played a crucial role in the Digital Pathology Association (DPA) Regulatory and standards Taskforce and FDA collaborations. The successful outcome was that WSI for primary diagnosis was recommended to become a class II instead of class III device in the United States. She also played an integral role and led the entire regulatory, clinical and medical affairs trajectory within Philips Digital Pathology Solutions (DPS) for Whole Slide Imaging devices to be marketed for “HER-2” as well as for “Primary Diagnosis” in as well US as in EU, CAN, Singapore and part of APAC. Esther is currently Chair of the DPA Regulatory and Standards Taskforce where she is spearheading regulatory and standards clarifications for interoperability and computational pathology as well as working on reimbursement in DP.
Pat Adams, Senior Genomic Liaison, Regional Trainer, Genomic Health
For the past 17 years, I have worked in molecular diagnostics within oncology. My experience includes; hereditary cancer testing, genomic assays for determining risk of recurrence and chemotherapy benefit, circulating tumor cell assays for treatment decisions in prostate cancer as well as pan cancer comprehensive genomic testing in both tissue and blood. I believe that to bring the full value of precision medicine to patients, all aspects of the testing process must be optimized. This includes the identification of patients who would benefit from testing, ordering appropriate tests at the earliest opportunity, efficient processing of prior authorization requirements, rapid send out of specimens, reflex testing established where appropriate and results received by provider without delay. Most recently, my focus has been on working with pathologists on optimizing the retrieval and processing of tissue specimens for NGS. I believe that in striving to change medical practice, it is incumbent on industry to build effective collaborations with all parties involved in testing if patients are to receive timely information to help them with treatment decisions. For the past 4 years, I have also been involved in mentoring students interested in careers in the Life Sciences at the University of Connecticut. One of the students I mentored is now a colleague. I believe that by supporting students with exceptional skills and commitments, our industry with advance to its full potential.
Neeraj Adya, Head of Diagnostics, GenMab
Neeraj Adya has over 19 years of expertise in the In Vitro Diagnostics (IVD) medical device industry, specifically in developing and supporting diagnostic assays. He had been a Pharmacodiagnostics (PDx) Lead at BMS, enabling development of Companion/Complementary diagnostics in various therapeutic areas, including Oncology, Fibrosis, and Cardiovascular. In this role, he serves as a SME for medical device, provides PDx leadership for complementary and companion diagnostic activities by setting PDx strategy for various assets followed by managing a PDx team to execute on the strategy by facilitating delivery of all diagnostics by working with external diagnostic business partners. Prior to BMS, he was at Abbott Laboratories for over 15 years where he led cross-functional teams to develop blood screening diagnostics products for infectious diseases as well as development of new molecular companion diagnostic assays (CDx) with multiple Pharma partners in Oncology across multiple indications. Neeraj received his PhD in Molecular Biology from Case Western Reserve University at Cleveland, Ohio. Subsequently, he was a Postdoctoral Research Fellow at the National Human Genome Research Institute in NIH.
Andrew Aijian, Principal, DeciBio
Andrew Aijian is a Principal at DeciBio Consulting, where he leads market landscape, product development, and strategy engagements for a wide variety of stakeholders in the biotechnology and life sciences industries. Andrew’s areas of interest and expertise include oncology biomarkers and diagnostics, -omics technologies, pharmaceutical services, and business intelligence data aggregation and visualization. At DeciBio, Andrew has led CDx-related market evaluation and strategy engagements for stakeholders across the CDx landscape, include diagnostic manufacturers, pharmaceutical services providers, translational research tools companies, and pharmaceutical manufacturers. Andrew has also served as author and editor for DeciBio’s companion diagnostics and oncology diagnostics market research reports, and developed DeciBio’s Immuno-Oncology Biomarker Analysis Platform and associated database of I/O clinical trial biomarkers. Andrew earned his Ph.D. in Biomedical Engineering from UCLA, focusing on the development of microfluidic research tools for biomedical applications. He obtained his B.S. in Chemical and Biomolecular Engineering from the University of Notre Dame.
Jeff Allard, Founder and President, Lakeside Life Science
Jeff earned his Ph.D from Dartmouth College, in Biochemistry. Since obtaining his Doctorate, Dr. Allard has brought six “new to the world” diagnostic tests through FDA, with >30 FDA Clearances and Approvals. He has launched sixteen new products. He has authored over 100 scientific papers and abstracts, and invented, developed, and obtained FDA clearance for the first complexed PSA assay.
Paul Allard, COO, Lakeside Life Science
Paul Allard is a Registered Nurse and Cofounder of Lakeside Life Science. Paul saw the need to bring patients back to the foreground of clinical research. He has a proven history of clinical site management as well as a vision to bring academic centers and community centers together to further medical research. Paul manages all day-to-day operations of the company.
Andy Beck, CEO, PathAI
Andy earned his MD from Brown Medical School and completed residency and fellowship training in Anatomic Pathology and Molecular Genetic Pathology from Stanford University. He completed a PhD in Biomedical Informatics from Stanford University, where he developed one of the first machine-learning based systems for cancer pathology. He is board certified by the American Board of Pathology in Anatomic Pathology and Molecular Genetic Pathology. Prior to co-founding PathAI, he was on the faculty of Harvard Medical School in the Department of Pathology at Beth Israel Deaconess Medical Center. He has published over 110 papers in the fields of cancer biology, cancer pathology, and biomedical informatics.
Flora Berisha, Director of Companion Diagnostics, Daiichi Sankyo
Flora Berisha is a Director of Companion Diagnostics, at Daiichi Sankyo Pharma. Flora received her BS in Biochemistry and Master Degree in Biology from City University of New York. She currently lead CDx development for multiple projects in the oncology portfolio. Prior to Daiichi Sankyo, Flora was at Kyowa Hakko Kirin Pharma as a Senior Manager. At KHK she focused on strategic biomarker selection, development and translation into CDx assays. She was the CDx lead on representing the strategies to external partners and regulatory agencies. Prior to KHK, Flora was at BristolMyers Squibb where she progressed through the ranks gaining valuable experience in GLP and clinical Bioanalysis, biomarker and CDx assay development from design control through commercialization. In addition to Flora’s industry experience, she is currently an Adjunct Professor in the Department of Biology at CUNY (City university of New York) where she teaches anatomyphysiology and biology over a decade.
Matthew Clark, Director, Scientific Services, Elsevier
Matthew Clark, Ph.D., Director of Scientific Services at Elsevier, has broad experience in pharmaceutical research and development. He has led teams in discovery research in large and small pharma, and in the scientific software and data industries. His research spans synthetic chemistry, free-energy calculations, informatics and predictive modeling of drug properties, safety pharmacology, and clinical adverse events. Dr. Clark works with leading pharmaceutical companies to help address cross functional informatics issues through data integration and predictive modeling. His team recently published a significant study of how well animal studies predict human results in a collaboration with Bayer Pharmaceuticals.
Nic Dracopoli, Chief Scientific Officer, Delfi Diagnostics
Nicholas (Nic) Dracopoli, Ph.D. is Chief Scientific Officer at Delfi Diagnostics, a seed stage cancer diagnostics company based in Baltimore, MD. Previously he led oncology translational science teams at Bristol-Myers Squibb and Janssen. Prior to joining the pharmaceutical industry, he spent several years in the biotechnology industry at Sequana Therapeutics. Nic obtained his bachelor’s degree and doctorate from the University of London and completed post-doctoral fellowships at the Memorial Sloan-Kettering Cancer Center in New York City, NY and the Massachusetts Institute of Technology (MIT) in Cambridge, MA. Subsequently, he served as an Assistant Director at the Whitehead/MIT Genome Center and as a Section Chief at the National Center for Human Genome Research at the National Institutes of Health. Nic has authored more than 70 scientific publications and has extensive experience in the fields of genomics, molecular biology and cancer research.
Colin Enderlein, Associate, DeciBio
Colin Enderlein has been active in precision medicine innovation and CDx commercialization at multiple phases of the R&D value chain in both the public and private sectors. Following the completion of his graduate work at The Karolinska Institute, Colin worked with the business development team at Seattle Children’s Research Institute to establish industry partnerships with a focus on curing childhood diseases. From here, Colin joined the business development team at NanoString, where activities focused on CDx partnering and execution, and technology due diligence. He is currently an Associate with DeciBio Consulting, where he specializes in research related to I/O therapies and their associated biomarkers, spanning both the pharmaceutical and genomic tools markets.
Mark Girardi, Vice President, Boston Healthcare Associates
Mark Girardi has over 30 years of experience in life sciences, in vitro diagnostics, and medical devices commercialization and reimbursement. He has had roles in product management, sales and marketing, and most recently in strategy consulting. Mr. Girardi joins Boston Healthcare from GfK Health, a global consultancy and market research firm, where he was Senior Vice President responsible for the MedTech consulting practice. Prior to joining GfK, Mr. Girardi spent five years at Predictive Biosciences as VP of Sales and Marketing. He also served as Senior Director of Marketing at Z-Tech Medical where he was responsible for commercialization of the company’s breast cancer screening devices. As a Director of Marketing at Cytyc Corporation (now Hologic), he managed the worldwide launch of the Thin Prep Imaging System. Mark has also held senior marketing positions at Genzyme Genetics and Millipore. Mr. Girardi received his BS in Chemistry from Merrimack College and an MS in Analytical Chemistry from the University of New Hampshire.
BJ Kerns, VP, Scientific Collaborations, HTG Molecular Diagnostics
BJ Kerns has more than thirty years of marketing and business development experience along with a successful track record in diagnostics. BJ has helped HTG penetrate the clinical research market and develop its diagnostic applications utilizing our unique qNPA system for clinically relevant gene expression signatures.
Prior to joining HTG Kerns was the director of integrated solutions and molecular diagnostics at Promega Corp. Inc. A seasoned diagnostics executive, Kerns held several positions at Ventana Medical Systems Inc., including director of women’s health, director of strategic marketing and senior director of product technical support in operations. While at Ventana she launched the company’s first FDA-cleared companion diagnostic PATHWAY ® HER-2. Kerns has also managed a variety of functions at BioGenex and Becton Dickinson, including business development, sales and marketing, and research and development.
Jeffrey Kim, VP, Senior Clinical Application Scientist, Advanced Cell Diagnostics
Jeffrey Kim, PhD, is the Senior Clinical Application Scientist at Advanced Cell Diagnostics. His research interests include the development and applications for diagnostic tests as well as evaluating biomarkers across various assay platforms. He has led collaborations with both academic and pharma partners to develop effective and impactful CDx strategies. Jeff earned his PhD in molecular biology at the University of Connecticut, investigating the impact of nutrient metabolism on gene expression to alter chronic disease states. He then completed a postdoctoral fellowship at the University of California-Davis, looking at oncometabolite metabolism in renal cell carcinoma, and the role of docosahexaenoic acid-derived metabolites on tumor angiogenesis. He previously completed a fellowship at the National Institutes of Health, examining the influence of various fatty acids on brain development by combining the powerful tools of mass spectrometry and imaging.
Matt Kuruc, Vice President of Business Development, Biotech Support Group
Matt Kuruc is a serial entrepreneur with a special focus on functional proteomic biomarkers and technologies. As Vice President of Business Development for Biotech Support Group, he enlists collaborators for a new commercialization plan featuring: a) variant sub-populations (also known as proteoforms) of proteolytic regulating proteins called Serpins, with functional protein reporting features that clearly distinguish differences between cancer patients and normal/healthy individuals, and b) a measurable cancer profile obtained from blood, that can be modeled with categorical biomarker proteins taken from inflammation, blood coagulation, and complement.
Matt Marton, Director, Companion Diagnostics & Genomics, Merck & Co.
Matthew Marton is Director of Clinical Genomics in Merck & Co.’s Molecular Biomarkers & Diagnostics department, where his team has deployed predictive biomarkers as patient enrichment assays on multiple technology platforms in over a dozen Merck clinical studies. His current work focuses on the CoDx strategy of novel genomic assays as molecular diagnostics, and he is a contributor to several CLSI documents involving molecular diagnostic testing in oncology. Prior work at Merck focused on technology/method development and biomarker discovery, with an emphasis on quality control of molecular profiling assays. Earlier in his career, Dr. Marton worked with Drs. Stephen Friend and Lee Hartwell at the Seattle Project, a drug discovery think tank, which led to the founding of Rosetta Inpharmatics, a biotechnology company that was acquired by Merck in 2001. At Rosetta and subsequently at Merck, he led scientific efforts to create a GLP-like high throughput functional genomics laboratory. Dr. Marton completed post-doctoral training at the NIH and holds a PhD from Princeton University and a Certificate in Biomedical Regulatory Affairs from the University of Washington.
Hannah Mamuszka, CEO, Alva10
Hannah Mamuszka is the Founder and CEO of Alva10, a consultancy that focuses on bringing diagnostics to the forefront of Precision Medicine by partnering with payers and diagnostic developers to create a new value-based healthcare model. Ms Mamuszka has spent 20 years in biotech and diagnostics, with extensive experience in both drug and diagnostic development, validation, and commercialization. Prior to founding Alva10, Ms Mamuszka was VP of Business Development at Exosome Diagnostics, where she led some of the earliest deals in the liquid biopsy diagnostic space. Earlier in her career, she was Global Director for Pharma Services at Exiqon A/S (now QIAGEN), and worked as a scientist on the NDA for Bortezmib (Velcade) at Millennium Pharmaceuticals (now Takeda). She regularly speaks on issues regarding advancement of technology in healthcare, is a Board of Directors for two diagnostic companies and writes a column on the value of diagnostics for the Journal of Precision Medicine.
Nuala McCabe, Head of Biomarker Research, Almac Diagnostics
With the continued advancement of the next generation sequencing technology, RNA-Seq is rapidly emerging as a principal discovery technology. RNA-Seq has the potential to detect novel transcripts and structural variants such as alternative splicing events and gene fusions and can also identify allele-specific expression, disease-associated single nucleotide polymorphisms (SNP), contributing to our understanding about disease causal variants in cancer. However RNA-Seq data is complex and difficult to interpret, often requiring extensive bioinformatic capabilities. Almac Diagnostics has developed an optimised RNA-Seq platform alongside proprietary bioinformatics pipelines and software solutions to report and visualise this myriad of data in an intelligently simplified manner. The Almac claraT Total mRNA Report includes 92 gene expression signatures, 100 single gene drug targets and over 7,000 additional biology linked genes, categorised by all 10 Hallmarks of Cancer. By analysing multiple biologies in parallel, the claraT Total mRNA Report supports the identification of novel insights, highlighting consensus signatures within, and between, the Hallmarks of Cancer. A case study demonstrating the utility of the claraT Total mRNA Report will be discussed.
Jose Moreno, Clinical Associate Professor of Urology, Thomas Jefferson University
Jose G Moreno, M.D. received his bachelor of science degree in biology from Loyola Marymount University in Los Angeles, California in 1983, and his medical degree from the University of Southern California School of Medicine in 1987. He served his general surgery residency at the University of California at Irvine, and a surgical oncology fellowship at the City of Hope in Duarte, California. He completed his urology residency at Thomas Jefferson University Hospital in Philadelphia. Dr. Moreno has worked on circulating prostate cancer cell research since 1991, and he has been awarded 4 US patents. He has been a principal investigator in a number biomarker clinical trials. He is a Clinical Associate Professor of Urology at Thomas Jefferson University Hospital, and he has been in his current private practice since 1995. He has served as President of the medical staff at Pottstown Memorial Medical Center, and President of the Urology Association of Pennsylvania. He is certified in DaVinci robotic surgery and has extensive experience with female pelvic reconstruction procedures.
Oscar Puig, Translational Medicine Team Lead, Oncology, Bristol-Myers Squibb
Oscar Puig was the Chief Scientific Officer at Phosphorus, a genetic diagnostic company founded in 2016 that develops diagnostics for complex genetic diseases and software for clinical data management and analysis. We currently commercialize three genetic panels (Reproductive Health, Cardiology, and Oncology). Prior to that, he was a Biomarker Leader in Oncology at the Roche Innovation Center in New York. He earned his Ph.D. at the University of Valencia, Spain, and carried out postdoctoral research at the European Molecular Biology Laboratory, in Heidelberg, Germany, and in the lab of Bob Tjian, at UC Berkeley, CA. Before joining Roche in 2012, he worked at Merck and at the University of Helsinki, where he is a docent. Dr Puig has over 40 publications in peer-reviewed journals.
Martin Shaw, Senior Director, Development Manager – AroCell
Martin Shaw has worked widely with novel cell and tissue injury biomarkers and their application to toxicology and drug discovery. Martin has participated in industry-wide consortia on the qualification on biomarkers for use in preclinical toxicology studies and phase I clinical trials. Martin has published several review articles on the application of biomarkers in drug discovery and he has lectured at many conferences, including twice being guest speaker at the FDA.